RxNorm Names

Review RxNorm Normal Forms

COLGATE MAX FRESH INTENSE (sodium fluoride) paste, dentifrice
[Mission Hills S.A. de C.V.]

Permanent Link:

http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c9bb958f-214c-4229-8660-5b2a19c0cd6c

Category	DEA Schedule	Marketing Status
HUMAN OTC DRUG LABEL		OTC monograph final

NOTE:MOST OTC DRUGS ARE NOT REVIEWED AND APPROVED BY FDA, HOWEVER THEY MAY BE MARKETED IF THEY COMPLY WITH APPLICABLE REGULATIONS AND POLICIES. FDA HAS NOT EVALUATED WHETHER THIS PRODUCT COMPLIES.

Drug Label Sections

Description
Clinical Pharmacology
Indications & Usage
Contraindications
Warnings
Precautions
Adverse Reactions
Overdosage
Dosage & Administration
How Supplied
Patient Counseling Information
Supplemental Patient Material
Boxed Warning
Patient Package Insert
Highlights
Full Table of Contents
Medication Guide

Drug Facts

Active ingredient

Sodium fluoride 0.24% (0.15% w/v fluoride ion)

Purpose

Anticavity

Use

helps protect against cavities

Warnings

Keep out of reach of children under 6 years of age.

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

adults and children 2 years of age and older	brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
children 2 to 6 years	use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
children under 2 years	ask a dentist of physician

Inactive ingredients

sorbitol, water, hydrated silica, PEG-12, sodium lauryl sulfate, flavor, cellulose gum, tetrasodium pyrophosphate, cocamidopropyl betaine, sodium saccharin, zinc oxide, methylcellulose, FD&C blue no. 1, D&C red no. 33

Questions?

1-800-468-6502

Dist. by:
COLGATE-PALMOLIVE COMPANY
New York, NY 1002

PRINCIPAL DISPLAY PANEL - 170 g Tube Carton

Colgate®
Anticavity Fluoride Toothpaste

NEW INTENSE FRESHNESS

Max Fresh®
WITH
GERM-FIGHTING STRIPS

Removes 90% of
Odor Causing Bacteria!*

INTENSE MINT WITH WHITENING

NET WT 6.0 OZ (170 g)

Principal Display Panel - 170 g Tube Carton

COLGATE MAX FRESH INTENSE
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:65954-554
Route of Administration	DENTAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (FLUORIDE ION)	FLUORIDE ION	2.4 mg in 1 g

Inactive Ingredients
Ingredient Name	Strength
SORBITOL	564.38 mg in 1 g
WATER	116.15 mg in 1 g
HYDRATED SILICA	227.5 mg in 1 g
POLYETHYLENE GLYCOL 600	30.54 mg in 1 g
SODIUM LAURYL SULFATE	14.99 mg in 1 g
CARBOXYMETHYLCELLULOSE SODIUM	6.5 mg in 1 g
SODIUM PYROPHOSPHATE	25 mg in 1 g
COCAMIDOPROPYL BETAINE	12.5 mg in 1 g
SACCHARIN SODIUM	3.5 mg in 1 g
ZINC OXIDE	1.5 mg in 1 g
METHYLCELLULOSE (25 MPA.S)	0.95 mg in 1 g
FD&C BLUE NO. 1	0.02 mg in 1 g
D&C RED NO. 33	0.011 mg in 1 g

Product Characteristics
Color	BLUE	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description
1	NDC:65954-554-60	1 in 1 CARTON
1		160 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part355	12/08/2011

Labeler - Mission Hills S.A. de C.V. (812312122)

Revised: 01/2013

Document Id: cbfdd8ed-6bd1-44fb-95ea-aeefd34dc060

Set id: c9bb958f-214c-4229-8660-5b2a19c0cd6c

Version: 2

Effective Time: 20130108

Mission Hills S.A. de C.V.

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